Regulatory Coordinator
2 settimane fa
The Regulatory Coordinator leads the operational regulatory activities, ensuring full compliance with local and international requirements. They manage a team through functional reporting lines, support project execution, and act as the main technical and organizational reference point.
Dettagli sul cliente
Our client is an Italian company operating in the national ingredients sector for the cosmetics, food, nutraceutical, and pharmaceutical industries. The company provides not only raw materials but also technical expertise, marketing services, and application laboratories for the development of formulations and prototypes.
Descrizione
The
Regolatory Coordinator
will be responsible for:
- Lead and supervise the regulatory team, assigning tasks and monitoring deadlines, while actively participating in regulatory activities.
- Ensure compliance of cosmetic, food, and nutraceutical products across EU and non-EU markets.
- Prepare, review, and submit regulatory documentation (dossiers, notifications, registrations, labels, claims).
- To be updated on national and international regulations and liaise with authorities and external partners.
- Collaborate with R&D, Production, Marketing, Sales, and QA to support new product development and launches.
- Provide guidance to the team, monitor KPIs, and contribute to process improvements for efficiency and compliance.
Profilo del Candidato
- Degree in Pharmacy, Chemistry, Biology, Food Science & Technology, or related fields.
- 5+ years in regulatory roles, including 2+ years leading a team.
- Master's or specialized Regulatory Affairs courses (preferred).
- Deep knowledge of EMA, AIFA, FDA, EFSA guidelines; EU regulations (cosmetics 1223/2009, food 178/2002 & 1924/2006), GMP/GDP, REACH, CLP.
- Dossier management and regulatory database expertise.
- Fluent in English, written and spoken.
- Degree in Pharmacy, Chemistry, Biology, Food Science & Technology, or related fields.
- 5+ years in regulatory roles, including 2+ years leading a team.
- Master's or specialized Regulatory Affairs courses (preferred)
- Deep knowledge of EMA, AIFA, FDA, EFSA guidelines; EU regulations (cosmetics 1223/2009, food 178/2002 & 1924/2006), GMP/GDP, REACH, CLP.
- Dossier management and regulatory database expertise.
- Fluent in English, written and spoken.
offerta di lavoro
Lead a passionate regulatory team and shape global compliance for innovative cosmetic, food, and nutraceutical products.
Desired Skills and Experience
Regulatory Affairs
Cosmetic Regulation (EU 1223/2009)
Food & Nutraceutical Regulation (EU 178/2002, 1924/2006)
Pharmaceutical Compliance
GMP/GDP
REACH & CLP
FDA / EMA / EFSA Guidelines
Dossier Preparation & Submission
Regulatory Documentation
Labeling & Claims Compliance
Regulatory Databases
Document Management Systems
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